FDA 510(k)

CloSYS® Dry Mouth Sensitive Mouth Rinse

K-Number: K250390 · 2025-05-19

Decision Date2025-05-19

Product CodeLFD

DecisionSubstantially Equivalent

Device Summary

CloSYS® Dry Mouth Sensitive Mouth Rinse is a medical device manufactured by Rowpar Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2025-05-19 under approval number K250390. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CloSYS® Dry Mouth Sensitive Mouth Rinse?

CloSYS® Dry Mouth Sensitive Mouth Rinse is a medical device that received FDA 510(k) clearance on 2025-05-19. It is manufactured by Rowpar Pharmaceuticals, Inc.. The 510(k) number is K250390.

When was CloSYS® Dry Mouth Sensitive Mouth Rinse approved by the FDA?

CloSYS® Dry Mouth Sensitive Mouth Rinse received FDA 510(k) clearance on 2025-05-19, under approval number K250390.

What company makes CloSYS® Dry Mouth Sensitive Mouth Rinse?

CloSYS® Dry Mouth Sensitive Mouth Rinse is manufactured by Rowpar Pharmaceuticals, Inc..

What is the FDA product code for CloSYS® Dry Mouth Sensitive Mouth Rinse?

The FDA product code for CloSYS® Dry Mouth Sensitive Mouth Rinse is LFD.

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Related Devices (Code: LFD)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.